FDA issues warning about heart pump linked to deaths

A troubled heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration's decision to issue a warning about the risk that it could perforate a wall of the heart.

Tiny Impella pumps, about the size of a candy cane, are threaded into blood vessels to take control of the heart's work in patients undergoing complex procedures or life-threatening conditions.

The FDA said the device's manufacturer, Abiomed, should have alerted the agency more than two years ago, when the company first posted an update on its website about the perforation risk. Such a notice, the FDA added, would have led to a much broader official warning to hospitals and doctors.

The warning is the latest in concerns raised in recent years about the deadly side effects of cardiac devices, particularly those that take over the heart's role in circulating blood. This is the third major FDA action for an Impella device in a year.

A series of studies have suggested that Impella cardiac devices increase the risk of death in patients with unstable medical conditions. Meanwhile, the device's manufacturer has spent millions of dollars promoting the device and giving consultations to cardiologists and grants to hospitals.

Since Abiomed's first warning about Impella complications in October 2021, the FDA has received 21 additional reports of heart wall injuries linked to patient deaths, according to Audra Harrison, a spokeswoman for the agency.

The FDA classified the warning issued last week as the most serious type of action that could be taken for a product that can cause death or serious injury, before being removed from the market. The warning still allows use of the device, with a risk update required for the 243-page instruction manual that accompanies the pump.

There are currently 66,000 Impella pumps in the United States and 26,000 similar devices in Australia, Canada, France, India and other countries.

The number of Impella-related injuries has struck some cardiologists as concerning. Some doctors have said the role of the pumps has already been called into question, citing a lack of high-quality studies establishing whether the devices offer more benefit than harm. Some have also wondered whether a call for greater caution in a thick instruction booklet could prevent deaths.

“I think cardiologists are already extremely careful,” said Dr. Rita F. Redberg, a cardiologist and professor at the University of California, San Francisco, who has been critical of the devices. “Saying you're addressing 49 deaths by saying 'be careful' isn't addressing the problem at all.”

Johnson & Johnson MedTech bought Abiomed in 2022. Dr. Seth D. Bilazarian, senior vice president of Abiomed, said in a statement that 300,000 Impella devices have been used on patients worldwide in more than a decade. There have been no reported cases of heart wall perforations related to the product's design or manufacturing, he said.

“We are proud of the positive impact our technology is having on patients facing life-threatening conditions,” said Dr. Bilazarian.

Asked why Abiomed hadn't flagged the fatal risk sooner, Johnson & Johnson MedTech said it was putting broad improvements in place. The company said heart wall lesions are rare and represent a “known complication during invasive cardiac procedures.”

Since 2013, research has highlighted the possibility that the device severs vessels and causes severe bleeding.

FDA records show the company attributed the heart wall lesions to “operator manipulation,” urging that use of the device be paired with imaging tools to avoid puncturing delicate heart tissue. Older adults, women and people with heart disease are particularly at risk, the agency said.

Pumps are temporary implants, adapted to the right or left heart chamber with different levels of pumping power. They are often used after a patient has had a severe heart attack and the heart loses the ability to move blood through the body. The devices tend to be used on very sick patients, many with a mortality risk of between 40 and 50%.

If a wall of the heart is torn by a device, “that's a surgical emergency that people very rarely survive from,” said Dr. Boback Ziaeian, a cardiologist and assistant professor of medicine at the University of California, Los Angeles. Angeles.

The FDA's new warning stems from a lengthy agency inspection last year of Abiomed's headquarters in Massachusetts, which led to a warning letter in September. Inspectors filed numerous complaints that the agency said should have been reported and also discovered a bulletin dated October 2021 that outlined the risk of laceration, according to the FDA

The bulletin, which the company said it posted on its website and an app, described the heart wall perforations as a “rare complication” first noted in January 2018. Abiomed was expected to submit a “surveillance report correction or removal” to the FDA within 10 days of notification, according to Ms. Harrison, a spokeswoman for the agency.

Abiomed said it had incorporated advice on how to use the device safely into its medical training and sent an alert letter to doctors late last December.

Dr. Bilazarian said Abiomed counted all tears in the walls of the heart's left chamber that occurred during a procedure “regardless of whether they were directly related to patient outcome.”

Last year the company issued two other major warnings related to Impella pumps that the FDA deemed linked to the risk of serious injury or death.

In June, the company warned that the pump might malfunction if it hit an artificial heart valve, linking it to four deaths and 26 injuries. The company also addressed the issue with an update to the device's instructions, FDA records show.

Impella heart pumps were first cleared for use in 2008, and their use was disputed by cardiologists even before the recent spate of problematic reports. When the single model of the device was approved by the FDA after further review in 2015, company-sponsored studies found that 73 percent, or 44 of 60 patients who met the criteria for use, survived a month after the operation.

By 2022, an FDA-commissioned study showed a similar outcome for 23 surviving patients in a group of 33. of the other 70 patients monitored in the same study, only 19% of them, or 13 people, survived one month after using the Impella device.

The FDA supported the device but urged doctors not to use it in patients suffering from organ failure and severe neurological injury.

Impella devices have increasingly taken the place of intra-aortic balloon pumps, which were once used to pump blood through the vessels of very ill patients and fell out of favor after a 2012 study questioned their validity. 'effectiveness.

However, several studies have since concluded that Impella devices are associated with higher mortality rates than balloon pumps and many more bleeding complications.

“When you look at the quality of the evidence supporting this device, it's pretty small to have for a high-risk device like this,” said Dr. Nihar Desai, deputy chief of cardiovascular medicine at Yale School of Medicine and a researcher. author of four studies on Impella devices.

The company has reported benefits from using Impella devices in non-emergency procedures in which doctors place stents, or tiny metal tubes, to open vessels near the heart. Other studies conducted in a single hospital and without a comparison group have shown survival benefits. Supporters of the device say it may be helpful in some patients.

Dr. Srihari S. Naidu, a professor of medicine at New York Medical College, said it is valuable to have Impella devices on hand. “The onus is on us as doctors and the community to make sure we approve the appropriate devices, that we have enough evidence to support their use, that we use them in the areas where we have the most evidence, and that we develop the skill set that keep them safe,” he added.

Dr Naidu said he had not received funding from Abiomed.

Medicare pays hospitals about $71,000 each time the device is used on a patient. Medicare data for 2022, the most recent year available, shows Abiomed spent $6.3 million on consultations, meals and research payments for doctors and grants of up to $50,000 to hospitals.

Those expenses were broken down into about 24,000 payments, which were made to about 9,500 U.S. cardiologists who perform surgeries. The company has made similar payments since at least 2016, spending $3.7 million to $7.5 million each year.

Johnson & Johnson MedTech bought Abiomed, which primarily sold Impella devices, in late 2022 for $16.6 billion. Johnson & Johnson reported in a securities filing $1.3 billion in device sales for 2023, largely driven by purchases of an Impella model listed in recent alerts.

In reporting on the outsized bleeding rates linked to the Impella devices, Dr. Desai, of Yale, also noted that its payments are much higher than the balloon pump, creating an urgent need for rigorous studies on how to best treat the patients.

“You hate to think that this is part of that story, but I think we would be naive to think that it can't be part of the story,” he said.

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